Cleared Traditional

HEARSAVER (K962292) - FDA 510(k) Clearance

K962292 · Emtech Laboratories · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
137d
Days
-
Risk

K962292 is an FDA 510(k) clearance for the HEARSAVER. Classified as Protector, Hearing (insert) (product code EWD).

Submitted by Emtech Laboratories (Hardy, US). The FDA issued a Cleared decision on October 29, 1996 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Emtech Laboratories devices

Submission Details

510(k) Number K962292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1996
Decision Date October 29, 1996
Days to Decision 137 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 89d · This submission: 137d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EWD Protector, Hearing (insert)
Device Class -